Table 135Outcome data from randomised trials of first-line chemotherapy for advanced/metastatic bladder cancer

HR, hazard ratio; OR, overall response; CR, complete response; Neu, neutropenia; Throm, thrombocytopenia; Anae, anaemia; Sep, neutropenic sepsis; Muc, mucositis; Leuc, leucopenia; Neuro, neurotoxicity; SAT, severe acute toxicity; Stoma, stomatitis; Gran, granulocytopenic fever

Study/ comparatorsOverall survivalProgression-free survivalGrade 3-4 toxicities, %Other, %Quality of life
Rate, %Median
months
HR (95% CI)Rate, %Median
months
HR (95% CI)NeuThromAnaeSATSepMucToxic deaths
(n)
von der Maase (2005) 5 yrs5 yrsQoL maintained over time on both arms, improved emotional functioning and pain.
GC (n=203)13.414.01.09 (0.88-1.34)9.47.71.09 (0.89-1.34)715727111%
vs. MVAC (n=202)15.315.2p=0.6611.98.3p=0.6382821712223%
Bellmunt (2012) 4.6 yrs4.6 yrs
PCG (n=312)2015.80.85 (0.72-1.02)148.30.87 (0.74-1.03)6435206
vs. GC (n=314)1812.7p=0.75117.6p=0.1135152153
Bellmunt (2012) Primary bladder tumours only
PCG (n=254)15.90.80 (0.66-0.97)
vs. GC (n=259)11.9p=0.025
Lorusso (2005)
LeucNeuro
GC (n=43)12.3336.535212455
vs. PCG (n=42)15.329849362000
Bamias 2004
MVAC +GCSF (n=109)3214.21.52 (1.11-2.08)9.41.73 (1.24-2.42)3668122
vs. DC +GCSF (n=111)249.3p=0.02556.1p=0.0029191641
Sternberg 2006 7.3 yrs7.3 yrs
FeverWBC
HD-MVAC (n=134)24.615.10.76 (0.58-0.99)18.79.50.73 (0.56-0.95)102220101
vs. MVAC (n=129)13.214.9(mortality HR)10.18.1p=0.017261762171
Bamias 2013 1 yr1 yr
DD-MVAC (n=63) vs.6619388.520811502
DD-GC (n=63)6218377.814810440
Loehrer 1992 6 yrs19.7 mo6 yrs19.7 mo
LeucGran
C (n=120)1.68.2p=0.0021.64.3101100
vs. MVAC (n=126)6.812.53.710241016175
Mead 1998 1 yr
Fever
CMV (n=108)2970.68 (0.51-0.90)5.50.55 (0.41-0.73)1055
vs. MV (n=106)164.5p=0.0065
(Mortality HR)
3p=0.0001
(Risk of progression)
200
Hillcoat 1989 2 yrs
HeamNausea
CM (n=53)8.7p=0.7105.0p=0.132744202
vs. C (n=55)7.2102.872500
Pizzocaro 1991
Leuc
MVAC (n=14)141477
vs. MC (n=14)7777
Petrioli 1996 21 moG 2-4
Leuc
MVEC (n=29)251337212517
vs. MVECa (n=28)7.49.5p=0.358261016
Dogliotti (2007)
GC (n=55)6412.88.33531204
vs. GCarbo (n=55)379.87.746382611
Dreicer 2004 FACT-BL: no significant differences over time between study arms
MVAC (n=44)15.48.767213791
vs. CaP (n=41)13.8p=0.655.2p=0.242910501
Bellmunt 1997
Stoma
MVAC (n=24)12.516213301
vs. M-CAVI (n=23)21.79p=0.0343330
De Santis (2012) 4.5 yrs4.5 yrsNo differences between arms for changes in global QoL. Inconclusive data.
Leuc
GCarbo (n=119)7.69.30.94 (0.72-1.22)3.45.81.04 (0.80 to 1.35)53484593
vs. M-CAVI (n=119)9.28.1p=0.645.04.2641947214

From: 5, Managing locally advanced or metastatic bladder cancer

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Bladder Cancer: Diagnosis and Management.
NICE Guideline, No. 2.
National Collaborating Centre for Cancer (UK).
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